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Completed

NCT Number: NCT02870400

A Study to Examine the Safety and Tolerability of Single Ascending Doses of REGN2477

The primary objective of the study is to assess the safety and tolerability of single ascending doses of REGN2477 in healthy women not of childbearing potential.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Antwerp, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy women not of childbearing potential between 18 and 65 years of age, with no significant health issues or clinically significant abnormal laboratory findings
  • A body mass index (BMI) between 18 to 30 kg/m2, inclusive
  • Provide a signed informed consent

Exclusion criteria

  • Significant illness or history of significant illness
  • Clinically significant abnormal CBC, clinical chemistry, and urine analysis at screening
  • Current smoker or former smoker who has stopped smoking within 3 months prior to screening
  • Positive urine drug test results during screening, or history of drug or alcohol abuse
  • Donation or loss of, blood within 8 weeks prior to screening, or plasma up to 14 days prior to screening
  • History of diabetes
  • Abnormal blood pressure (BP)
  • History of gynecological disorders or malignancies; history of breast malignancies; or history of benign gynecological or breast lesions that require medical treatment or follow up
  • Reduced renal function
  • Known history of chronic hepatitis or HIV
  • Clinically significant ECG abnormalities
  • Participation in any clinical research study within 30 days, or 5 halflives, of the study drug, whichever is greater, or for longer periods per regional requirements, prior to the screening visit
  • Exposure to any biological drugs within 3 months of the screening visit (the name of the drug and duration of previous exposure will be recorded). Vaccination within 4 weeks of screening visit.
  • History of hypersensitivity reactions to vaccines or other biologics
  • History of hypersensitivity to doxycycline or other tetracycline antibiotics
  • History of osteoporosis requiring osteoporosis treatments such as PTH, bisphosphonates, and denosumab
  • Subject using hormone replacement therapy or thyroid replacement therapy will be excluded, unless they have been on stable doses of such therapy for at least 6 months and will remain on the same stable dose through the duration of the trial
  • Use of systemic glucocorticoids, including oral glucocorticoids, for more than 10 days, within 3 months prior to screening.

Treatment and study plan

REGN2477

Drug

Participants will receive ascending doses of REGN2477

Placebo

Drug

Participants will receive matching placebo

Primary outcomes

  1. Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477

    Time frame: Day 1 to Day 113

Secondary outcomes

  1. Pharmacokinetic profile of REGN2477, assessed via serum concentrations of REGN2477 over time

    Time frame: Day 1 to Day 113

  2. Immunogenicity of REGN2477, as determined by the presence or absence of Anti-drug antibody (ADA) to REGN2477 over time

    Time frame: Day 1 to Day 113

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Intravenously and Subcutaneously Administered REGN2477 in Healthy Women Not of Childbearing Potential

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 17, 2016
Registry last updated
Feb 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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